MabionCD20 Compared to MabThera in Lymphoma Patients

NCT02617485 | Completed Phase 3 Results DMC

• 1 other identifier: MabionCD20-002NHL
• Study Type: interventional
• Target: 143
• Locations: 7 countries
• Sites: 35

Brief Summary

The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20 (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell lymphoma.

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4])

  Area under the serum concentration-time curve from time zero (Day 1) to final time point measured after the first administration (Week 1) until Week 4 (AUC(W1-W4)). PK blood samples for this endpoint were drawn at Day 1 (before and after the first infusion), Day 8 ± 1 (7 days after first infusion), Day 15 ± 1 (14 days after first infusion), Day 22 ± 2 (before and after completion of the second infusion).

  Baseline to Week 4

• Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26])

  Area under the serum concentration-time curve from time zero to final time point measured from Week 13 until Week 26 (AUC\[W13-W26\]). PK blood samples for this endpoint were drawn at Day 85 ± 4 (before and after completion of the fifth infusion), Day 106 ± 4 (before and after completion of sixth infusion), Day 127 ± 4 (before and after completion of the seventh infusion), Day 148 ± 4 (before and after completion of the eight infusion), Day 155 ± 4 (one week after last infusion) and Day 176 ± 4 (one month after last infusion).

  Week 13 to Week 26

Secondary Outcomes (9)

• Ctrough (Before 8th Infusion)

  Week 22

• Cmax (Post 5th and 8th Infusion)

  Week 13 (5th infusion) and Week 22 (8th infusion)

• Kel (Post 5th and 8th Infusions)

  Week 13 (5th infusion) and Week 22 (8th infusion)

• T1/2 (Post 5th and 8th Infusions)

  Week 13 to Week 16 and Week 22 to Week 26

• CLss (Post 5th and 8th Infusions)

  Week 13 to Week 16 and Week 22 to Week 26

Other Outcomes (1)

• Immunogenicity

  from baseline to Week 46

Study Arms (2)

MabionCD20

EXPERIMENTAL

A course of MabionCD20 consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles. Intervention: Drug: Rituximab

Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Cyclophosphamide; Drug: prednisone

MabThera

ACTIVE COMPARATOR

A course of MabThera consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles. Intervention: Drug: Rituximab

Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Cyclophosphamide; Drug: prednisone

Interventions

Rituximab DRUG

375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.

Also known as: MabThera®, MabionCD20®

MabThera; MabionCD20

Doxorubicin DRUG

50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle

Also known as: Hydroxydaunorubicin

MabThera; MabionCD20

Vincristine DRUG

1.4 mg of vincristine per square meter, up to a maximal dose of 2 mg, administrated IV on day 1 of each chemotherapy cycle

Also known as: Oncovine

MabThera; MabionCD20

Cyclophosphamide DRUG

750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle

MabThera; MabionCD20

prednisone DRUG

100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle

MabThera; MabionCD20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histological confirmed CD20 (cluster of differentiation 20) positive diffuse large B cell lymphoma (DLBCL)
• Patients that had been diagnosed according to the WHO classification;
• Performance status ≤ 2 on the ECOG (Eastern Cooperative Oncology Group) / WHO (world Health Organization) scale, performance status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated;

You may not qualify if:

• Life expectance less than 6 months;
• Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment;
• Rituximab, other anti-CD20 mAb (Monoclonal Antibodies) drug treatment, treatment with any cell depleting therapies - e.g., anti-CD4 (cluster of differentiation 4) anti-CD5 (cluster of differentiation 5), anti-CD3 (cluster of differentiation 3), anti-CD19 (cluster of differentiation 19), anti CD11 (cluster of differentiation 11), anti-CD22 (cluster of differentiation 11), BLys/BAFF (B Lymphocyte Stimulator/B-cell activating factor) within 1,5 years before screening;

Sponsors & Collaborators

• Mabion SA: lead

Study Sites (35)

University Clinical Center Banja Luka

Banja Luka, 78 000, Bosnia and Herzegovina

Location

University Clinical Center Sarajevo

Sarajevo, 71 000, Bosnia and Herzegovina

Location

University Clinical Center Tuzla

Tuzla, 75 000, Bosnia and Herzegovina

Location

General Hospital Zenica

Zenica, 72 000, Bosnia and Herzegovina

Location

GH "dr.Josip Bencevic"

Slavonski Brod, 35000, Croatia

Location

CH Merkur

Zagreb, 10000, Croatia

Location

CHC Zagreb

Zagreb, 10000, Croatia

Location

HEMA

Tbilisi, 0112, Georgia

Location

S. Khechinashvili state University clinic

Tbilisi, 0179, Georgia

Location

Medulla - Chemotherapy and Immunotherapy Clinic

Tbilisi, 0186, Georgia

Location

Institut of Oncology, Hematology Department

Chisinau, 2025, Moldova

Location

Wojewódzki Szpital Specjalistyczny w Legnicy, Oddział Hematologiczny

Legnica, 59-220, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr1, Klinika Hematologii i Transplantacji Szpiku

Lublin, 20-081, Poland

Location

Szpital Wojewódzki w Opolu, Oddział Hematologii i Onkologii Hematologicznej

Opole, 45-061, Poland

Location

MTZ Clinical Research Sp. Z o.o.

Warsaw, 02-106, Poland

Location

Clinical Hospital Center Zemun

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Zvezdara

Belgrade, 11000, Serbia

Location

Military Hospital Academy

Belgrade, 11000, Serbia

Location

Public utility "Chernivtsi regional clinical oncology dispensary", Day patient department

Chernivtsi, 58013, Ukraine

Location

Municipal Institution "Dnipropetrovsk City multi-field Clinical Hospital #4", Oncology and medical radiology department

Dnipropetrovsk, 49102, Ukraine

Location

Regional Clinical Hospital of Ivano-Frankivsk, Hematology Department.

Ivano-Frankivsk, 76008, Ukraine

Location

Regional Clinical Oncology Dispensary, Chemotherapy Department

Ivano-Frankivsk, 76018, Ukraine

Location

Kharkiv Regional Clinical Oncology Centre, Deartment of haematology

Kharkiv, 61070, Ukraine

Location

National Institute of Cancer, Department of chemotherapy

Kiev, 03022, Ukraine

Location

Kiev City Clinical Oncological Center, Department of chemotherapy #2

Kiev, 03115, Ukraine

Location

Utility Enterprise "Kirovograd regional oncology dispensary"

Kirovohrad, 25011, Ukraine

Location

Kryvyi Rih Oncology Dispensary, Dnipropetrovsk Highway

Kryvyi Rih, 50048, Ukraine

Location

Volyn' Regional clinical hospital, Haematology Department

Lutsk, 45634, Ukraine

Location

State institution "Institute for haemotopathology and haemotransfusion of National Academy of science of Ukraine

Lviv, 79044, Ukraine

Location

Mykolayiv Region Clinical Hospital, Heamotology department

Mykolayiv, 54058, Ukraine

Location

Poltava regional oncology hospital, heamotherapy department

Poltava, 36011, Ukraine

Location

Regional clinical Hospital named after Novak, Hematology Department

Uzhhorod, 88000, Ukraine

Location

Vinnitsya Regional Clinical Oncology Dispensary, Chemotherapy Department,

Vinnitsya, 21029, Ukraine

Location

Regional Oncology dispensary

Zaporizhzhia, 69040, Ukraine

Location

Zaporizhzhya Regional Clinical Hospital, Deartment of haematology and intensive therapy

Zaporizhzhia, 69600, Ukraine

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Doxorubicin; Vincristine; Cyclophosphamide; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Adam Tuszyner
• Organization: Mabion S.A.

a.tuszyner@mabion.eu

+48504441105

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: December 1, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: January 1, 2018
• Last Updated: October 25, 2023
• Results First Posted: October 25, 2023

Record last verified: 2023-01

Locations

SE (3); UA (17); MO (1); BO (4); GE (3); CR (3); PL (4)